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  2. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

  3. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]

  4. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis

  5. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...

  6. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]

  7. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    Download as PDF; Printable version; In other projects Wikidata item; Appearance. move to sidebar hide An exemplary boxed warning, as seen in context, in FDA's ...

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    Free premium casino-style slots and classic video poker by the creators of authentic PC & Mac casino slots from IGT, WMS Gaming, and Bally!

  9. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)